SMG 1114.1

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF THE COMMISSIONER

OFFICE OF THE CHIEF SCIENTIST

Effective Date: 07/08/2011

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1.  OFFICE OF THE CHIEF SCIENTIST (DAE).

Provides strategic leadership, coordination, and expertise to support scientific excellence, innovation and capacity to achieve the Food and Drug Administration’s public heath mission. Key activities include:

1. Fostering development and use of innovative technologies to meet public health needs

2. Supporting scientific excellence and the professional development of FDA scientists in all areas (i.e. population/statistical, review, laboratory and manufacturing sciences), including through the Commissioner’s Fellowship Program, continuing education, and scientific interactions with universities and others

3. Providing strategic leadership and support for high quality, collaborative, scientific activities that advance regulatory science and address important public health issues concerning FDA regulated products, including their evaluation, quality, safety and effectiveness

4. Exercising on behalf of the Commissioner direct line authority over, and providing executive leadership, management, and policy direction to, the National Center for Toxicological Research to serve as a national FDA resource for mission driven regulatory science

5. Assisting the Commissioner by providing general oversight of and informal direction to the Office of Women’s Health and the Office of Minority Health

6. Providing cross-agency scientific coordination (e.g., for emerging technologies, scientific issues involving multiple agency components, standards coordination, the FDA Science Board, and science communication)

7. Supporting scientific outreach, training, and collaboration, including research, development and Critical Path activities that engage other Agencies, global regulatory partners, academia, innovators, and consumers

8. Supporting science and public health activities to effectively anticipate and respond to counter-terrorism and emerging deliberate and natural threats (e.g. chemical, biological, radiological and nuclear) to US and global health and security including through the Office of Counter-terrorism and Emerging Threats

9. Providing core scientific leadership and technical expertise, and ensuring agency capacity, for advanced bioinformatics activities needed to support FDA programs. Serve as an Agency and government resource for excellence, methods development, outreach and partnerships in advanced bioinformatics science

10. Leading agency efforts to protect and enhance scientific integrity, and, where substantive scientific differences of opinion arise and require review at the FDA level, addressing them through appropriate processes intended to protect both FDA’s mission and the integrity of its science

2.  AUTHORITY AND EFFECTIVE DATE.

The functional statements for this Office were approved by the Secretary of Health and Human Services, effective July 8, 2011.

STATUS (I, R, C)	DATE APPROVED	LOCATION OF CHANGE HISTORY	CONTACT	APPROVING OFFICIAL
Initial	08/23/2007	N/a	OC/OO/OM/OMP	Secretary of the Department of Health and Human Services
Revision	01/13/2009	N/a	OC/OO/OM/OMP	Commissioner of the Food and Drug Administration
Revision	08/07/2009	N/a	OC/OA/OM/OBOHCP/OMP	Secretary of the Department of Health and Human Services
Revision	07/08/2011	N/a	OO/OM	Secretary of the Department of Health and Human Services